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Completed
NCT06478979
The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)
Conditions: Idiopathic Normal Pressure Hydrocephalus (iNPH)
Sex: All
Ages: 60 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Deepsonbio
Location: Hallym University Dongtan Sacred Heart Hospital Hwaseong-si Gyeonggi-do
Summary
This clinical trial aims to explore the effectiveness and safety of gait improvemen of Neuclare, a science medical device, for patients with Idiopathic Normal Pressure Hydrocephalus (iNPH) Through methods such as Timed Up \& Go Test (TUG), 10m gait , iNPH grading scale), etc, gait improvement before and after using Neuclare will be evaluated.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 60 to 90, regardless of gender
* Individuals exhibiting gait disturbances along with at least one of the following symptoms: cognitive impairment or urinary incontinence
* Evans' index \> 0.3)
* When the symptoms in 2) and 3) cannot be fully explained by other neurological or non-neurological diseases
* Diagnosis of INPH based on the Investigator's clinical judgement based on criteria as described in the INPH Guidelines
Exclusion Criteria:
* Patient with pathological lesions in the brain identified by MRI
* A person who is confirmed to have organic brain lesions (e.g., cerebral edema, cerebral hemorrhage, cerebral infarction, cerebrovascular malformation, brain tumor, etc.) on a brain MRI.
* Patients with metabolic disorders such as thyroid dysfunction, hyperglycemia, hypoglycemia, liver or kidney dysfunction, and long-term use of drugs that will cause cognitive decline (e.g., anticholinergic drugs)
* History of psychiatric disorder other than the inclusion criteria.
* A person with a severe history of cancer/tuberculosis
* A person who has contact dermatitis or sensitive skin abnormalities
* Patients with a high fever of 40 degrees Celsius or higher based on eardrum body temperature
* A person whose bleeding is identified due to a common procedure or surgery that may affect vital signs
* A person who is unable to perform MRI tests
* A person with an allergic reaction to MRI contrast agents such as Definity or Gadovist.
* Other cases where the investigator judged that it is difficult to participate in the study
* Patient with behavioral and psychological symptoms of dementia (BPSD) that make cooperation in the clinical trial difficult
* Patients with severe cognitive impairment, defined as an MMSE score of 17 or below
* Patients who have undergone shunt surgery in the past year
* Patients with a history of uncontrolled thyroid, liver, or kidney dysfunction
* Patients taking medications that affect gait, cognition, or urinary tract function and who have had a change in medication regimen within the past 3 months.
* Patients who have undergone a cerebrospinal fluid drainage test within the past 1 month.
Source: ClinicalTrials.gov (NCT06478979). StuddyBuddy aggregates publicly available trial information.